The present invention relates generally to medical apparatus and methods. More particularly, the present invention relates to devices and methods for the attachment of expandable devices and the like within a patient""s body cavity, such as the stomach, intestine or gastrointestinal tract.
In cases of severe obesity, patients may undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and/or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the intestinal tract. Procedures such as laparoscopic banding, where a device is used to xe2x80x9ctie offxe2x80x9d or constrict a portion of the stomach, or the placement of intragastric balloons can also achieve these results.
Endoscopic procedures that have been used to assist weight loss have been primarily focused on the placement of a balloon or other space-occupying device in the patient""s stomach to fill portions of the stomach to provide the patient with the feeling of fullness, thereby reducing food intake. To accomplish these procedures, an endoscope is utilized to guide the balloon through the patient""s mouth and down the esophagus to the stomach. Usually these procedures have allowed placement of the device for 6-12 months, and are coupled with counseling and other types of psychological support.
Many of the conventional surgical interventions require the patient to submit to an intervention under general anesthesia, and can require large incisions and lengthy recovery time. The less invasive procedures, although clinically efficacious in many cases, suffer from complications ranging from deflation of the devices to insufficient anchoring of these devices resulting in unsustained weight loss, stomach erosion, bowel obstruction and even death.
Many of these devices are neither robust enough nor are they adequately secured within the stomach to sustain long term implantation. As a result, many implanted devices are implanted in such a manner as to remain unattached or free-floating within the stomach. Further, due to the caustic nature of stomach acids and other factors, many of the implants deflate and migrate into the intestine, causing bowel obstructions and in some cases death. Also, many devices are not well designed for removal, leading to additional technical difficulties for the clinician.
The present invention provides for the improved methods and apparatus for implanting and anchoring space-occupying devices into the gastrointestinal system of a patient, e.g., the stomach of the patient, that can be deployed in a minimally invasive manner such as transesophageal endoscopy. The invention allows greater access to procedures and devices by patients who might not otherwise be treated surgically as xe2x80x9cmorbidly obesexe2x80x9d (at or above a Body Mass Index (BMI) of 40 kg/m3), but who may just be moderately obese or overweight (BMI of between 25 to 40 kg/m3). In addition, patients who require more invasive surgery for an unrelated ailment, may need a minimally invasive way to lose the weight prior to their more invasive procedure, thereby reducing the risks associated with general anesthesia, or otherwise enabling the more invasive procedure.
Expandable devices that may be inserted into the stomach of a patient may be maintained within the stomach by anchoring or otherwise fixing the device to the stomach wall of the patient. Such expandable devices, e.g., an inflatable balloon, may comprise two portions, an inner portion and an outer portion, the inner portion being able to maintain its shape, regardless of the integrity of the outer portion. Other expandable balloon devices which may be used may maintain their expanded shape and desired volume, independent of any small leaks that may develop over time or they may be configured to maintain a volume of the space-occupying device which can be adjusted in-situ, to change the size of the device after implantation.
The space-occupying devices preferably have a tethering region for attachment to one or more fasteners. The fasteners are configured such that portions of the fasteners may extend at least partially through one or several folds of the patient""s stomach wall, thereby maintaining the device within the patient""s stomach, but do not extend external to the patient""s body. The fasteners may thus be affixed to the stomach walls by deploying the fasteners and manipulating the tissue walls entirely from the inside of the organ.
Such fasteners may be formed in a variety of configurations, e.g., helical, elongate, ring, clamp, and they may optionally be configured to be non-piercing. For example, sutures may simply be used to wrap around or through a tissue fold for tethering the space-occupying devices. Alternatively, non-piercing biased clamps may also be used to tether the device within the stomach.